A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 7/14/2016 |
| Start Date: | August 2002 |
| End Date: | October 2003 |
A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
The primary objective of this study was to establish the long-term tolerability and safety
of istradefylline treatment in subjects with Parkinson's disease treated with
levodopa/carbidopa. In addition, treatment response and maintenance of response were
assessed.
of istradefylline treatment in subjects with Parkinson's disease treated with
levodopa/carbidopa. In addition, treatment response and maintenance of response were
assessed.
Inclusion Criteria:
Eligible subjects were:
- male or female
- at least 30 years of age
- had completed participation in a prior double-blind istradefylline trial
- met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1
and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was
defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
- had been treated with levodopa for at least 1 year
- had been on a stable Parkinson's disease regimen within normal therapeutic ranges
including levodopa for at least 4 weeks before Baseline
- were currently taking at least 4 doses of levodopa per day (3 doses per day if at
least 2 doses contained slow-release formulation)
- had predictable end-of-dose wearing-off
Exclusion Criteria:
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